OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
FDA 510(k) clearance K133940 · decided 2014-03-28
Clearance details
- K-number
- K133940
- Device name
- OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
- Applicant
- Biomet UK, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-23
- Decision date
- 2014-03-28
- Days to decision
- 95 days
- Clearance type
- Traditional
- Product code
- HRY
- Device class
- 2
- Regulation number
- 888.3530
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a recall (Z-1018-2023) | Biomet, Inc. | 2023-01-26 |
| Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicate recall (Z-0624-2021) | Biomet, Inc. | 2020-12-17 |
| Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The pro recall (Z-0956-2017) | Zimmer Biomet, Inc. | 2017-01-06 |